Enlicitide (Lipfendra – Merck), an oral proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor, has been approved by the FDA to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). It is the first oral PCSK9 inhibitor to be approved in the US; the other FDA-approved PCSK9 inhibitors (alirocumab [Praluent], evolocumab [Repatha], and lerodalcibep [Lerochol]) and the PCSK9-directed small interfering RNA inclisiran (Leqvio) are injected subcutaneously.1 Lipfendra was...
RELEASE
The FDA has approved Leqembi Iqlik, the subcutaneous (SC) formulation of the amyloid beta-directed monoclonal antibody lecanemab, for once-weekly initiation dosing in patients with Alzheimer's disease (AD). The SC formulation was previously approved only for maintenance treatment in patients who had received IV lecanemab for at least 18 months.1
CLINICAL STUDIES — FDA approval of the new SC starting regimen was based on data from substudies of the open-label CLARITY AD extension trial that found that lecanemab exposure with once-weekly subcutaneous injection was similar to that with IV administration of the drug.2
SC administration of lecanemab was associated with less frequent systemic reactions than IV administration, but severe localized reactions leading to treatment discontinuation have occurred with the SC formulation. The risk of amyloid-related imaging abnormalities with …